Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy

Overview

The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.

Full Title of Study: “Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy Versus Standard Colonoscopy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2017

Interventions

  • Device: Device Assisted Colonoscopy
    • This will be similar to the standard colonoscopy except the endocuff device will be used.
  • Device: Standard Colonoscopy
    • No endocuff device will be used on the study participants undergoing standard colonoscopy.

Arms, Groups and Cohorts

  • Experimental: Device Assisted Colonoscopy
    • Device assisted colonoscopy (DAC) is a technique of attaching disposable devices like “Endocuff” or “Transparent cap” at tip of colonoscope to improve mucosal visualization and stability.
  • Active Comparator: Standard Colonoscopy
    • Standard colonoscopy is the endoscopic examination of the large bowel and the distal part of the small bowel with a camera on a flexible tube passed through the anus.

Clinical Trial Outcome Measures

Primary Measures

  • Adenoma detection rate (ADR) as determined by Colonoscopy
    • Time Frame: intraoperative
  • Complete adenoma resection rate (CARE) for adenoma > 10 mm in diameter as determined by Colonoscopy
    • Time Frame: intraoperative

Secondary Measures

  • Cecal Intubation Rate (CIR)
    • Time Frame: intraoperative

Participating in This Clinical Trial

Inclusion Criteria

1. Patients undergoing first screening colonoscopy 2. Patients undergoing subsequent surveillance colonoscopies with known history of prior colon polyps detected on prior screening colonoscopies. 3. Ability to provide informed consent. Exclusion Criteria:

1. Previous surgical resection of any part of the colon 2. history of colon cancer 3. history of inflammatory bowel disease 4. use of antiplatelet agents or anti-coagulants that precluded removal of polyps 5. Poor general condition 6. History of polyposis syndrome or hereditary nonpolyposis colorectal cancer 7. Inability to give informed consent.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nirav C Thosani, Assistant Professor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Nirav Thosani, MD, Principal Investigator, The University of Texas Health Science Center, Houston

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